Saturday, July 03, 2010

Health Consumer Activist Group Subject to Legal Threats -- Send Help

The very, very short version: an independent health-care-fraud muckraking association is being intimidated, via a law suit with a $10 million dollar claim. The suit has been filed on behalf of a for-profit laboratory that does millions of dollars of business providing tests that enable quack or questionable "therapies" for heart disease, autism, and other conditions.

The for-profit laboratory has deep pockets and has associates with even deeper pockets.

If you want to support health-care-fraud muckraking, go here to donate. If you are a skeptic or dislike legal bullying, you should donate.

Chelationwatch became a separate site in July of 2004, linking to previously-published articles critical of chelation therapy for anything other than heavy-metal poisoning.

Chelation is the accepted medical treatment for a set of rare conditions: heavy-metal poisoning (lead, mercury, and so on). That is the only medically-accepted use for chelation. However, it has been proposed as a questionable therapy for a number of conditions.

Enter novel theories about autism causation and the internet. In 1996, Bernard Rimland of the Autism Research Institute (ARI) published a guide for alternative autism health practioners, which became known as the "Defeat Autism Now! (DAN!) protocol". In 2001, Sally Bernard and co-authors published "Autism: a novel form of mercury poisoning" in a fringe medical journal, Medical Hypotheses.
What's the accepted treatment for mercury poisoning? Why, chelation. In a 2005 position paper, ARI reported:

The Autism Research Institute convened our first mercury detoxification Think-Tank in February 2001, in Dallas Texas, in response to the need for information on how best to treat mercury toxicity. The resulting Consensus Report published in May, 2001, has been widely distributed in hard copy and on the Autism Research Institute website.

This opened a whole new avenue for "autism therapy providers" (many of whom were not physicians) to provide "therapy" for "autism as heavy metal poisoning". Another key word is "detoxification".

The hypothesis that autism is a form of mercury poisoning has been found to be false. Thoroughly and completely false. That didn't stop the chelation enthusiasts.

A 2008 article by Katie Duzan points out some of the problems (emphasis added)

The problem with DAN goes beyond certification.Let's break down the
general protocol for treating a new patient at a DAN office. First,
they take blood, urine and stool samples. These go to labs for testing
to determine any deficiencies or issues. Sounds legitimate, right?
Well, consider that there are never any children that have their tests
come back 'normal'. And if anything comes back abnormal, the DAN doctor
aggressively treats the problem with medication or other means.

Still
sounds okay, but start thinking in terms of reality. What are the odds
that every single child a DAN doctor sees is in dire need of medical
assistance? There are parents that truly believe that every single
autistic child has a gut issue, metal toxicity or something else that
needs to be cleaned, cured or altered.

Barrett and his colleagues broadened their criticism of chelation to include chelation as an autism "treatment". In the view of responsible physicians, chelation as a treatment for autism is unnecessary and dangerous to the health of the child.

Chelation rests upon urine tests for "toxic loads" of heavy metals. In an article written for Quackwatch and republished at Chelationwatch, Robert Baratz, M.D., D.D.S., Ph.D. explains "Dubious Mercury Testing" (emphasis added)

Because mercury is ubiquitous, the body reaches a steady state in
which tiny amounts are absorbed and excreted. Thus, it is common to
find mercury in people's urine. Mercury can also be found in the blood,
because this is the major medium for transporting materials around the
body. Large-scale population studies have shown that the general
population has urine-mercury levels below 10 micrograms/liter.
Industrial workers, and dentists, who have regular exposure to mercury
vapor also have low values. Because urine-mercury levels represent the
chronic, steady state, exposure to the body of mercury, they are fairly
reliable indicators of past exposure, since they tend to even out the
peaks and valleys of transient rises and falls in the blood level.
Urine measurements should be performed on the first urine specimen of
the day, which would be the most concentrated, or (preferably) on a
24-hour urine specimen.

Urine mercury levels can be artificially raised by administering a
mercury scavenger (chelating agent) such as DMPS or DMSA, which collect
the small amounts of mercury from the body, concentrate them, and then
force them to be excreted. In other words, mercury that normally
recirculates within the body is now bound and excreted. The urine level
under such circumstances is artificially raised above the steady-state
level.... The use of a chelating agent
before testing—"provoked testing"—should be considered a scam. Anyone
told that a urine-mercury level produced after taking DMPS represents a
toxic state is being misled.

All patients underwent a provoked "urine toxic metals test" in which a urine sample is obtained after the patient receives a chelating agent. The chelating agent temporarily increases the excretion of mercury, lead, and/or other metallic substances that are present in trace amounts within the body. The test report, which typically states that the reported levels are elevated, is then used to claim that the child needs to be "detoxified" with chelation therapy

In 2009, three decisions from the U.S. Court of Federal Claims (the "vaccine court") ruled that there was no reliable evidence linking autism to specific vaccines (MMR) or vaccine ingredients such as thimerosal.

A number of articles followed, pointing out that some physicians and other health-care providers are still using chelation as a "treatment" for autism. As Arthur Allen noted in Slate Magazine:

....[A] Chicago laboratory that performs most of the chemical testing for alternative doctors like Bradstreet who treat autistics. Doctor's Data Inc., which tests about 100,000 urine samples for toxic metals each year, presents the results in such a way that it almost guarantees a finding of "toxicity" for each child.

According to a recent federal report on complementary medicine, about 72,000 children were chelated in 2007. Most of them were probably seen by doctors loosely allied to an organization called Defeat Autism Now! The doctors, naturopaths, and other practitioners in DAN! frequently order up exhausting regimens of testing for each child in the belief that people with autism are out of whack with nature. They test the children for viruses, bacteria, yeast, immune system elements, and brain antibodies, drawing copious amounts of blood, as well as spinal fluids and biopsy material, before prescribing immune globulins, vitamins, enzymes, and other pills and infusions. The tests and therapies run into the tens of thousands of dollars per child.

One of the more popular tests, in recent years, has been for traces of toxic metals. The testing methodology is explained here. In a nutshell, Doctor's Data classifies the level of mercury in the urine of a recently chelated child by comparing it with base-line levels in normal, unchelated children. Naturally, the chelated levels are higher. That's what chelators do: They leach metals out of tissue. Plus, everyone has a little bit of mercury in them, because trace amounts are in our air, water, and food. What's remarkable is that so many people have relied on the data from these tests.

Many patients are falsely told that their body has dangerously high levels of lead, mercury, or other heavy metals and should be "detoxified" to reduce these levels. This article explains how a urine test is used to defraud patients.

The Bottom Line

The urine toxic metals test described above—whether provoked or not—is used to persuade patients they are toxic when they are not. I believe that several agencies can and should do something to stop this deception.

If the FDA has jurisdiction over the software used to generate the test reports, it could ban its use. State licensing boards could prohibit the use of provoked testing and discipline practitioners who use it.

State laboratory licensing agencies could prohibit testing of provoked specimens or order Doctor's Data to raise its reference ranges and to stop comparing provoked test results to these non-provoked ranges.

The Centers for Medicare & Medicaid Services' Division of Laboratory Services can also ban the testing of provoked specimens.

State attorneys general can seek injunctions based on violations of consumer protection laws.

In addition, all of these agencies can and should issue public warnings.

On July 27, 2009, The American College of Medical Toxicology published a Position Statement

It is, therefore, the position of the American College of Medical Toxicology that post-challenge urinary metal testing has not been scientifically validated, has no demonstrated benefit, and may be harmful when applied in the assessment and treatment of patients in whom there is concern for metal poisoning.

Several networks of fringe practitioners are using hair and urine tests from Doctor's Data to persuade patients to buy dietary supplements and/or undergo "detoxification" that they do not need. My advice is very simple. If you encounter a doctor who does either of these things, terminate your relationship, complain to your state licensing board, and e-mail me an account of what happened.

On June 18th, Doctor's Data filed suit against me, the National Council Against Health Fraud, Inc., Quackwatch, Inc., and Consumer Health Digest, accusing us of restraint of trade; trademark dilution; business libel; tortious interference with existing and potential business relationships; fraud or intentional misrepresetation; and violating federal and state laws against deceptive trade practices. (On June 29th, Consumer Health Digest was dropped as a defendant.) The complaint asks for more than $10 million in compensatory and punitive damages. The suit objects to seven articles on my Web sites:

Provoked testing (administering a chelating agent before collecting a specimen for heavy metals testing) yields unreliable results. This is the prevailing scientific belief and has been the basis for many government actions against practitioners who administered such tests. Like the attorneys' warning letters, their suit objects to my opinion that provoked testing is used to defraud patients, but it fails to challenge my reasoning. Many others have criticized provoked testing, but my analysis may be more conspicuous than the others.

The lawsuit also asks the court to muzzle me:

WHEREFORE, DOCTOR'S DATA, INC., Plaintiff, prays that this court enter an
order granting Doctor's Data a permanent injunction; direct them to remove or delete all disparaging statements and remarks pertaining to Doctor's Data from these or any web sites under their control; and prohibit them from publishing these or any other or additional such remarks on blogs, the aforesaid websites, or any other web sites pending the outcome of this litigation.

The Bottom Line

Very few people provide the type of information I do. One reason for this is the fear of being sued. Knowledgeable observers believe that Doctor's Data is trying to intimidate me and perhaps to discourage others from making similar criticisms. However, I have a right to express well-reasoned opinions and will continue to do so. If you would like to help with the cost of my defense, please follow the instructions on our donations page.

Comments

I'm looking into this, and it looks to me like even "alties" are leary of this. I'm working on a writeup of an incident from back in 2006, where Rashid Buttar said, "How could the head PhD for Doctors Data see thousands of his own company's tests showing heavy metals being excreted with TD-DMPS as the chelating agent say that TD-DMPS does not trans the dermal? Logic would dictate that if TD-DMPS does not cross the skin, but the provocation tests show excretion of heavy metals while non-provocation tests are negative, then the tests themselves are wrong!"

Thanks for pulling together this information. When someone publicly asks for proof of claims, the right thing to do is provide it, not sue them to try to shut them up. That goes x10 for medicine, since then you're dealing with human life and suffering.

I have a 9-page pre-mortem on this lawsuit on the evilpossum.weebly "cures" page. My main conclusion: the suit depends almost entirely on the contention that "quackwatch" is a commercial rather than "non-profit" organization. I think there's a strong possibility it will be dismissed or withdrawn this week.

But Barret clearly has conflicts of interest. He gets paid hundreds of thousands of dollars every year to do conferences for pharma sales reps. I also find it odd that Barret claims everything that can't be patented is quackery. He even goes after herbs, which are where we find some of the chemicals to make our medicines. He's filed thousands of frivolous suits against different doctors around the country (which were all thrown out by the judges) and then referenced his own suits as proof that those doctors were fraudulent. He seems like a corrupt individual to me and he seems to just be working for Pharmaceutical companies.

Stephen Barrett is in big trouble in the Doctor's Data v Barrett case.

BIG trouble.

You can follow the case at http:www.boleneport.com. There you can sign up for the newsletter, and follow the case as it happens.

Currently Barrett has filed a Motion to Dismiss the case, but there is little chance that will happen. His reason he wants a Dismissal? He claims he is "assisting the government..."

Next comes "discovery," a process where Barrett will have to cough up thousands of documents, then go into a video-taped Deposition where he will be forced to answer questions about his support network - those that helped him get his articles on the first page of search engines.

Barrett's lead attorney seems to have disappeared, and he has been LATE making EVERY filing deadline since the case began.

I guess I could check Tim Bolen's website. Or I could get ahold of the docket for the case and the motion to dismiss.

The docket shows that there have been motions for extra time to respond, and that those have been granted in whole or in part. That's not the same thing as "being late" to me.

The motion to dismiss is based on the SLAPP laws.

"Next comes "discovery," a process where Barrett will have to cough up thousands of documents, then go into a video-taped Deposition where he will be forced to answer questions about his support network - those that helped him get his articles on the first page of search engines."

Why? This sounds like a fishing expedition. How is getting articles on the front page of search engines (should this be true) pertinent to the case at hand? If this is the purpose of the lawsuit, then a dismissal under SLAPP is quite appropriate.